China’s guideline requires that the Class III medical device registration must submit a test report, and the test report should be issued by a certified medical device testing center. The following are the key points that manufacturers should pay attention to when doing the type testing of Class III medical device.
a) Product technical requirements (PTR)
b) Instructions and label samples:
c) The testing contract
a) Testing qualification
The manufacturer should check if the testing can be done at certain testing center. The qualification can be determined based on the product type and standards referred in the PTR
b) After confirming the testing center
Once the testing center is determined, the testing timeline and required samples for the testing shall be determined.
a) The manufacturer should send samples according to storage requirements
b) Signing the testing contract with the testing center
It is recommended to communicate with the testing center before signing the contract. Some testing centers need time to review the documents. The manufacturer can send the testing documents first. After the documents are confirmed, the manufacturer can send the testing sample and sign the testing contract.
a) Communication of product technical indicators and methods during the testing process;
b) Active track of the testing process
a) Modify and finalize the product technical requirements;
b) The testing center issues pre-evaluation opinions on product technical requirements.
a) Pay all the testing fees after the testing center calculate the expenses;
b) Receiving a registration test report;
c) Return the sample.
Type testing and 3rd party reviews are being encouraged, according to the newly-released Medical Device Amendment.
For more information about medical device type testing, please email info@ChinaMedDevice.com.
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